Status: Active Trial | Marker: EGFR

Title

Exploring the theragnostic value of osimertinib in EGFR-mutated lung cancer (THEROS) - A multicentric phase II study in patients with TKI-resistant EGFR-mutated lung cancer exhibiting early metabolic response to osimertinib

Study Number

NCT03810066

Indication

EGFR-mutated non-small-cell lung cancer (NSCLC) with acquired TKI resistance to erlotinib, gefitinib or afatinib who are “unknown” for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a standard plasma genotyping assay.

Primary objective

To study the rate of early metabolic responses to osimertinib in patients with EGFR-mutated NSCLC and acquired TKI resistance who are „unknown“ for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy and a negative finding for EGFR T790M in a standard plasma genotyping assay.

In- and exclusion Criteria

In- and Exclusion Criteria

• Acquired resistance to a first- or second-generation EGFR-TKI (e.g. afatinib, erlotinib, gefitinib) following initial benefit (defined as objective response, or stable disease for at least 3 months)
• No tumor rebiopsy available or absence of an informative result for EGFR T790M mutation status by a SoC molecular pathology test (e.g. Sanger sequencing, PCR-based genotyping, deep sequencing) of a rebiopsy of a progressive tumor lesion
• Negative finding from EGFR T790M mutation testing in plasma-derived DNA using a SoC assay (e.g. Roche Cobas)

Study design

Phase II, multicenter-study

Responsibilities

Universitätsklinikum Essen
Hufelandstrasse 55
45147 Essen, Germany

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
lungenkrebs@uk-koeln.de

Principal investigator

Prof. Dr. J. Wolf

Last Update: 13. June 2019